A comparison of the Optum Clinicogenomics Solid Tumor Database and the SEER Population-Based Cancer Registry.

Abstract

6635 Background: Real-world data (RWD) and real-world evidence (RWE) are increasingly utilized across a range of research and regulatory applications, including biomarker discovery, risk stratification, external control arms, and post-market surveillance. Two-thirds of FDA approvals in 2021 utilized genomic data and the growing interest in targeted therapies will likely continue this trend. While genomics or any one type of RWD alone yields an incomplete view of the patient journey, Optum’s clinicogenomic data links de-identified longitudinal clinical and claims data to next-generation sequencing (NGS) results. Ensuring the value of this data requires identifying and limiting biases and maximizing diversity. Methods: To evaluate the robustness and representativeness of Optum’s Clinicogenomic Solid Tumor Database, we compared demographic and clinical characteristics to the Surveillance, Epidemiology and End Results (SEER) database across 16 solid tumor types. Variables of interest included age at diagnosis, sex, self-identified race, year of diagnosis, and metastatic status. The Optum data was derived from clinical data that includes 156 million lives and claims data that covers 95 million lives. The solid tumor sub-cohort used for this analysis included 157,164 patients diagnosed between January 1, 2011, and December 31, 2021 with linked broad-panel NGS results. SEER Incidence Data included patients diagnosed between January 1, 2011, and December 31, 2018. Using the Optum data, we also report average continuous enrollment and sequential testing frequency across all solid tumor types. Results: The overall distributions of age at diagnosis, sex and race were similar across all cancer types, with a few exceptions. On average, SEER had a larger proportions of patients 80 years and older (15% vs 7.2%, all solid tumors) and of Asian race (7.1% vs 3.2%, all solid tumors). Cancer diagnoses in the Optum data increased year over year corresponding with the increasing availability and uptake of genetic testing in oncology, while the SEER data was equally distributed across all years. The average continuous enrollment for solid tumor patients was 8.1 years in the Optum data, and 13% of patients had sequential testing results from >1 time point. Conclusions: Given the increased reliance on RWD and RWE as part of the drug development and regulatory approval processes, ensuring the representativeness of clinicogenomic databases is paramount. This analysis of general patient characteristics across the Optum Clinicogenomics and SEER solid tumor databases found largely similar distributions of key variables. Observed differences between these two representative databases reflect the genetic testing landscape in oncology and provide the opportunity to investigate disparities related to accessing genetic services, corresponding targeted treatment options, and health outcomes.